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Friday, May 13, 2011

officer/ Sr. Officer/ Executive - Regulatory Affairs (APIs)


Summary
 

Experience:
1 - 4 Years
Location:
Mumbai
Compensation:
Salary will not be a constraint for the right candidate
Education:
UG - B.Sc - Any Specialization, ChemistryPG - M.Sc - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Drug Regulatory Dr.
Functional Area:
Healthcare, Medical, R&D
Posted Date:
12 May

Desired Candidate Profile

  • should have excellent written and spoken communication (English)
  • should be B.Sc/ M.Sc (Chemistry) 

Job Description

  • Preparation of DMF, Certificate of suitability (CEP) dossiers, technical packages amendments of DMFs/ dossiers 
  • Preparation of annual reports, knowledge of  ICH guidelines/ GMP
  • customer support document preparation
  • answering queries of Authorities/ Customers
  • Awareness of the requirements of submissions in US, Europe, Canada, Japan and other countries
Keywords: Regulatory Affairs API, US/ EU DMFs, Bulk drugs

Company Profile

We are a fast expanding pharmaceutical company, with a significant presence in Pharmaceutical Industry since six decades. With a turnover exceeding INR 650 Crores, Our business spans over 40 countries ranging from Asia to Europe. We possess a range of DMFs for our API’s, requisite registrations and dossiers exceeding 300. Our six manufacturing facilities in India have been accredited from global drug Regulatory Authorities including the FDA (USA), MHRA (UK) and MCC (South Africa). To Augment our dynamic plans, we need talented professionals with a proven track recode and commitment.
Contact Details
Company Name:
FDC Limited
Executive Name:
Human Resources - FDC LTD
Address:
FDC Limited
142/48, Swami vivekanand Road Jogeshwari (West)
MUMBAI,Maharashtra,India 400102
Email Address:

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